Trial to evaluate the Efficacy and Safety of NuSepin® in COVID-19 Pneumonia Patients

Phase 1

Conditions: COVID-19 Pneumonia Patients
MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2022-001152-42-BG

Lead Sponsor: Shaperon, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1134

Inclusion Criteria

An individual who meets all the following criteria will be eligible for the present clinical trial.
1)An individual who or whose legally authorized representative has fully informed of all pertinent aspect of the trial and IMP, voluntarily decided to participate in the trial and adherence to the trial-related requirements, and provided a written informed consent
2)An adult man or woman aged more than 19 years (or age of majority in his/her country) and older
3)A hospitalized patient with laboratory-confirmed SARS-CoV-2 infection by PCR test within 10 days (240 hours) prior to randomization.
4)At the time of randomization; whose clinical status is stage 4 (oxygenation by facial mask or nasal cannula) or 5 (non-invasive ventilation or high flow oxygen) on WHO 8-point ordinal scale
5)Pneumonia that satisfies all the following criteria at the time of randomization
(1) Confirmation of Lung infiltration (chest x-ray, CT, etc. within 48 hours before randomization)
(2) Patients with SpO2=94% at room air condition or on oxygen therapy
6)Planned first dosing of the IMP not later than 2 days after the initiation of standard of care (SOC), when given in combination with SOC for severe Illness (according to NIH Clinical Spectrum of SARS-CoV-2 Infection)
7)A score of 5 points or more (think sepsis”) on the NEWS 2 scale at the time of randomization

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 334

Exclusion Criteria

Individuals presenting with any of the following criteria at randomization will be excluded:
1)A patient whose clinical status is stage 3 or lower on the WHO 8-point ordinal scale (WHO 8-OS) at the time of randomization
2)An individual who requires endotracheal intubation, mechanical ventilation (WHO 8-OS stage 6), or extracorporeal membrane oxygen therapy (stage 7) at the time of randomization
3)A patient with multiorgan failure, shock, acute respiratory syndrome (ARDS)
4)A patient with renal dysfunction defined by eGFR less than 30mL/min/1.73m², or the use of hemodialysis or hemofiltration
5)Cholestatic liver disease (example: biliary obstruction, cholangitis, etc.) or hepatic dysfunction
6)Any of the following laboratory test results at the time of screening:
(1)Alanine aminotransferase (ALT) exceeding the upper normal limit (UNL) by 5 times
(2)Aspartate aminotransferase (AST) exceeding the upper normal limit (UNL) by 5 times
(3)Total bilirubin exceeding the upper normal limit by 3 times
7)An individual with HIV-positive results or who requires antiviral treatments against active hepatitis (HBV, HCV)
8)A patient with any of following infectious diseases (e.g., active tuberculosis, etc.) in the past or at present
A patient is diagnosed to have a respiratory viral or respiratory bacterial infection including active tuberculosis and excluding SARS-CoV-2 within 14 days prior to screening.
(However, those who have initially received a systemic anti-infective therapy based on clinical suspicion of a non-SARS-CoV-2 infectious disease are allowed to participate in the trial, only when definitive diagnosis of SARS-CoV-2 infection is made.)
9)A patient who uses mechanical ventilation (invasive or non-invasive) or oxygen therapy due to chronic lung diseases or neuromuscular disorders
10)A patient who requires oxygen therapy due to lung diseases other than COVID-19 pneumonia (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, cystic pulmonary disease, etc.), congestive heart failure (NYHA Class 3 or 4), pulmonary edema, etc.
11) An individual with a past medical history of hypersensitivity to the IMP and the standard therapies (Remdesivir, etc.) as well as to any ingredients of such drugs
12)An individual who has received any of the prohibited medications within the protocol-specified timeframes of enrollment in the clinical trial (e.g., live vaccines within 4 weeks of screening) [refer to Section 5.10.1]
13)A woman with childbearing potential who has tested positive in the pregnancy test performed before participating in the clinical trial
14)Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP not agreeing to ? use a highly effective method of contraception (hormonal contraceptives, intrauterine device (IUD), intrauterine system (IUS), vasectomy, intubation ligation, etc.); or use a double barrier method of contraception if the highly effective method is not possible (A combination between male condoms, female condoms, cervical caps, contraceptive diaphragms, and contraceptive sponges) during the course of the trial (until EOS visit); or ? donate the sperm until one month after the completion of the trial.
15)A patient who is expected to be discharged or transferred within 72 hours
16)A patient with less than 24 hours of life expectancy
17)An individual who is currently participating in another clinical trial, or who received other study drugs as part of another clinica